Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
- Registration Number
- NCT00426855
- Lead Sponsor
- Peter Moosmann
- Brief Summary
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
- Detailed Description
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Symptomatic recurrent or refractory indolent NHL or B-CLL
- Adequate organ and bone marrow function
- Karnofsky greater than 50%
- Candidates for autologous stem cell transplantation
- Secondary high grade lymphoma
- Concurrent severe medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bendamustine and Bortezomib Bendamustine Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section Bendamustine and Bortezomib Bortezomib Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section
- Primary Outcome Measures
Name Time Method Optimal Bendamustine Dosage for Further Studies Three weeks after treatment termination
- Secondary Outcome Measures
Name Time Method